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Intensity Modulated Radiation Therapy for Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00214422
First received: June 19, 2006
Last updated: August 1, 2014
Last verified: June 2014
  Purpose

BACKGROUND:

-This study represents a progression from findings in four previous NCI ROB protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain Magnetic Resonance (MR) biological images and co-register tissue in prostate cancer patients.

OBJECTIVES:

-The primary objective of the first portion of this study is to assess the feasibility of using IMRT to treat the at-risk lymph nodes in prostate cancer. Also, if feasible, we hope optimize this technique with experience.

ELIGIBILITY:

-This is a study of image guided, targeted radiation therapy in patients with high risk of nodal metastases from prostate cancer. Patients with prostate cancer who have more than 15% risk of lymph node (as defined by the Partin tables) metastasis will be eligible for this study.

DESIGN:

  • On the first 10 patients, we will perform approximately 5CT simulations throughout the course of their therapy. On each simulation, the initial treatment plan will be re-run. The dose-volume data from target and normal tissues will then be re-analyzed. From this analysis we will be better able to determine the size of margins needed to account for organ motion and changes such as varying amounts of gas in the bowel and fluid in the bladder. To the best of our knowledge, no such analyses have been published.
  • If the initial part of this trial is feasible, we will proceed to a phase I dose escalation trial of radiation to the at-risk lymph nodes. The primary statistical objective of the phase I portion of this study is to estimate the Maximum Tolerated Dose (MTD) of external beam radiation based on evaluating acute toxicity. The study will be conducted with a dose-escalation design with 3 patients in each dose cohort. If fewer than 2 of 3 patients experience an acute DLT than patients will be accrued to the next dose cohort. If 2 or more of 3 patients experience a DLT then the MTD will be exceeded and the prior, lower dose cohort will be considered the MTD. Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity.
  • Specific procedures and risks will be described in a separate consent to be obtained at the time of biopsy. Tissue samples will be processed for cDNA microarray testing and stored for future analysis in the Radiation Oncology Branch, NCI.
  • Anatomic Magnetic Resonance Imaging (MRI) and MR biological images of the prostate and pelvis will be obtained and tissue will be acquired with biopsy locations precisely translated (co-registered) to an MR image of reference. A fiducial marker (gold seed) will be left at the biopsy site as a fiducial marker to direct future radiation therapy to the prostate. If necessary, additional fiducial markers will be placed for prostate localization during treatment.

Condition Intervention Phase
Prostate Cancer
Radiation: External Beam Radiation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Image Guided Prostate and Pelvic Nodal Irradiation With Intensity Modulated Radiation Therapy (IMRT) in Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To assess the feasibility of using IMRT to treat the at-risk lymph nodes in prostate cancer (first 10 patients) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • To determine the maximum tolerated dose (MTD) of external beam radiation to pelvic lymph nodes of interest in patients receiving radiation therapy for prostate cancer (after the first 10 patients) [ Time Frame: Completion of Treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate long-term effects and toxicity following IMRT dose escalation to the pelvic nodes. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: September 2005
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
5040cGy to lymph nodes
Radiation: External Beam Radiation
Radiation will be given in dose escalations from 5040 cGy to a maximum of 5900cGy to lymph nodes.
Experimental: 2
5400cGy to the lymph nodes
Radiation: External Beam Radiation
Radiation will be given in dose escalations from 5040 cGy to a maximum of 5900cGy to lymph nodes.
Experimental: 3
5900cGy to the lymph nodes
Radiation: External Beam Radiation
Radiation will be given in dose escalations from 5040 cGy to a maximum of 5900cGy to lymph nodes.

Detailed Description:

BACKGROUND:

-This study represents a progression from findings in four previous NCI ROB protocols (02-C-0167A, 02-C-0207E, 03-C-0190B, 04-C-0171). In these previous works we have begun to develop techniques to obtain Magnetic Resonance (MR) biological images and co-register tissue in prostate cancer patients.

OBJECTIVES:

-The primary objective of the first portion of this study is to assess the feasibility of using IMRT to treat the at-risk lymph nodes in prostate cancer. Also, if feasible, we hope optimize this technique with experience.

ELIGIBILITY:

  • This is a study of image guided, targeted radiation therapy in patients with high risk of nodal metastases from prostate cancer.
  • Patients with prostate cancer who have more than 15% risk of lymph node (as defined by the Partin tables) metastasis will be eligible for this study.

DESIGN:

  • On the first 10 patients, we will perform approximately 5CT simulations throughout the course of their therapy. On each simulation, the initial treatment plan will be re-run. The dose-volume data from target and normal tissues will then be re-analyzed. From this analysis we will be better able to determine the size of margins needed to account for organ motion and changes such as varying amounts of gas in the bowel and fluid in the bladder. To the best of our knowledge, no such analyses have been published.
  • If the initial part of this trial is feasible, we will proceed to a phase I dose escalation trial of radiation to the at-risk lymph nodes. The primary statistical objective of the phase I portion of this study is to estimate the Maximum Tolerated Dose (MTD) of external beam radiation based on evaluating acute toxicity. The study will be conducted with a dose-escalation design with 3 patients in each dose cohort. If fewer than 2 of 3 patients experience an acute DLT than patients will be accrued to the next dose cohort. If 2 or more of 3 patients experience a DLT then the MTD will be exceeded and the prior, lower dose cohort will be considered the MTD. Secondary objectives of this study are to relate patterns in gene and protein expression to response and toxicity and to evaluate the frequency of late term toxicity.
  • Specific procedures and risks will be described in a separate consent to be obtained at the time of biopsy. Tissue samples will be processed for cDNA microarray testing and stored for future analysis in the Radiation Oncology Branch, NCI.
  • Anatomic Magnetic Resonance Imaging (MRI) and MR biological images of the prostate and pelvis will be obtained and tissue will be acquired with biopsy locations precisely translated (co-registered) to an MR image of reference. A fiducial marker (gold seed) will be left at the biopsy site as a fiducial marker to direct future radiation therapy to the prostate. If necessary, additional fiducial markers will be placed for prostate localization during treatment.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

ECOG performance status of 0, 1, or 2

Pathology report confirming adenocarcinoma of the prostate

Risk of lymph node metastasis greater than or equal to15% as defined by the Partin tables or biopsy proven positive lymph nodes

Tumor visible on MRI

No prior surgery, radiation, or chemotherapy for prostate cancer, with the exception of hormone therapy which may be given neoadjuvantly for up to four (4) months.

Age greater than 18 years old and less than 90 years old.

EXCLUSION CRITERIA:

Cognitively impaired patients who cannot give informed consent.

Patients with metastatic disease beyond the pelvis

Contraindication to biopsy

  • Bleeding disorder
  • PT/PTT greater than or equal to 1.5 times the upper limit of normal
  • Platelets less than or equal to 50K
  • Artificial heart valve

Contraindication to MRI

  • Patients weighing greater than136 kgs (weight limit for the scanner tables)
  • Allergy to MR contrast agent
  • Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices.

Pre-existing and active prostatitis or proctitis

Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214422

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Aradhana Kaushal, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00214422     History of Changes
Obsolete Identifiers: NCT00278356
Other Study ID Numbers: 050241, 05-C-0241
Study First Received: June 19, 2006
Last Updated: August 1, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Prostate
Radiation
Cancer
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014